TEDA-Based Sinomed’s Globally Pioneering Product Receives FDA Breakthrough Designation

Recently, the U.S. Food and Drug Administration (FDA) granted  Breakthrough Device Designation to COMETIU®, an Intracranial Self-Expanding Drug Stent System, and COMEX™, a balloon microcatheter, both independently developed by a subsidiary of Sino Medical Sciences Technology Inc. (Sinomed), a company based in TEDA. This marks the first time a China-made neurointerventional device has secured this certification. Notably,  COMETIU® stent becomes the first FDA-designated  breakthrough device for treating intracranial atherosclerotic stenosis (ICAS) in China and even the world, offering new hopes for millions of stroke patients worldwide. 

As the world’s first self-expanding nickel-titanium alloy drug-eluting stent system specifically designed for ICAS and delivered via microcatheter , the COMETIU® stent features precise drug release control, significantly reduced recurrence risks, and safe, effective operation. When used in combination with the COMEX™ balloon microcatheter, the system further shortens surgical time and minimizes surgical risks associated with device exchanges.

Founded in 2007 in the TEDA, Sinomed is Tianjin’s first company listed on the Sci-Tech Innovation Board (also known as STAR Market). The company has established an internationally competitive R&D, production, and operational framework, covering key interventional therapy fields such as cardiovascular, cerebrovascular, and structural heart diseases. Its flagship products, including coronary drug-eluting stents, coronary balloons, and intracranial rapid-exchange balloons, have been used in over 2.4 million procedures across more than 4,000 hospitals, benefiting hundreds of thousands of patients in China, Southeast Asia, and South America.